MODEL 20 DIGITAL PULSE RATE MONITOR— 510(k) K780937

Substantially Equivalent

Sentronix, Inc.

FDA 510(k) clearance K780937 for MODEL 20 DIGITAL PULSE RATE MONITOR, Substantially Equivalent on 1978-08-31. Applicant: Sentronix, Inc..

Clearance details

Applicant: Sentronix, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1978-06-08
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.